Methods for collecting body fluid

ABSTRACT

A body fluid is collected for testing for an analyte contained within the body fluid. The fluid is collected in an apparatus including a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit. A capillary test space is in fluid flow communication with the reservoir. The capillary test space is positioned to be in contact with the fluid in the reservoir after the fluid has accumulated to a predetermined transfer volume of fluid. The capillary test space is sized to wick the fluid from the reservoir when the fluid contacts the capillary test space.

TECHNICAL FIELD

This invention pertains to testing a body fluid for an analyte. Forexample, the present invention is applicable for testing glucose in abody fluid such as blood or interstitial fluid.

BACKGROUND

Numerous patents teach various ways for collecting a sample of bodyfluid and testing such fluid for an analyte such as glucose. Forexample, U.S. Pat. Nos. 5,823,973 and 5,820,570 describe methods andapparatus for obtaining, in one embodiment, interstitial fluid, which istested for glucose through IR absorption. These patents also describeuse of the disclosed inventions in colormetric and electro-chemicaltesting of glucose. U.S. Pat. No. 5,453,360 teaches a test strip forcolormetric testing for glucose. Blood is placed on a test stripcontaining various chemical components including a dye. The degree ofcolor change of the test strip indicates the amount of glucose. U.S.Pat. Nos. 5,508,171 and 5,628,890 teach electro-chemical testing. Bloodis placed on a test strip containing electrodes. Reaction of glucose onthe electrodes generates a current indicating the amount of glucosepresent in the blood.

Present development efforts are directed to testing very small volumesof body fluid (e.g. about 0.5 microliter). The use of such small volumesof fluid permits less painful collection of a fluid samples. However,small fluid volumes present additional challenges for analyte testing.For example, testing for analytes typically requires a fluid sample inexcess of a predetermined minimum volume. By way of non-limitingrepresentative example, a test may require a minimum sample size of 5microliter to yield reliable test results.

Furthermore, sample collection systems may receive a flow of body fluidover an extended time (e.g., 10 seconds or more) before a minimum samplevolume is collected. As a result, body fluid may be deposited on testcomponents (e.g., electrodes or colormetric test strips) before a fullsample is collected. Such premature deposit may initiate chemicalreactions on a test strip thereby consuming reagents before a reliabletest can be initiated. Further, such test components may be coupled tologic circuits for calculating an analyte's concentration based onreadings from the test strip. A premature deposit of an inadequatevolume of fluid sample may falsely inform logic circuits that testinghas initiated when, in fact, an adequate sample volume has yet to becollected.

Recognizing the problems of premature test initiation, the prior art hasdeveloped techniques for delaying test initiation until an adequatevolume of sample is collected. For example, logic circuits may have abuilt-in time delay which assumes a fixed period of time to collect anadequate volume of sample. Of course, such systems suffer from the factthere is no certainty that an adequate volume is collected during suchtime delay. Alternatively, to be conservative, such time delays mayfrequently be unnecessarily long. Additionally, U.S. Pat. No. 5,049,487teaches reading a reflectance of a side of a membrane. A fluid sample isplaced on the opposite side. When the sample is absorbed through themembrane, the change in reflectance is noted indicating testing maycommence. However, such a system suffers from chemical agents on themembrane being in contact with a sample prior to initiating testing.

Therefore, there is a need for a method and apparatus for collecting asample of body fluid to obtain an adequate volume of such fluid.

SUMMARY

According to a preferred embodiment of the present invention, a methodand apparatus are disclose for collecting a body fluid for testing foran analyte contained within the body fluid. The apparatus includes areservoir for receiving and collecting a flow of body fluid from adischarge end of a conduit. A capillary test space is in fluid flowcommunication with the reservoir. The capillary test space is positionedto be in contact with the fluid in the reservoir after the fluid hasaccumulated to a predetermined transfer volume of fluid. The capillarytest space is sized to wick the fluid from the reservoir when the fluidcontacts the entrance end. With the present invention, fluid iscollected within the reservoir at a rate of flow-limited by the conduit.When the reservoir is full, the collected fluid rapidly wicks into thecapillary test space. The capillary test space may contain testcomponents for testing for the analyte.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a sample collection apparatus with anelectro-chemical test strip shown removed;

FIG. 2 is an enlarged segmented view of the area of circle 2 in FIG. 1;

FIG. 3 is a side-sectional view of the apparatus of FIG. 1 showing thetest strip in place;

FIG. 4 is an enlarged segmented view of the area of circle 4 in FIG. 3;

FIG. 5 is a segmented top-plan view of a reservoir of the apparatus ofFIG. 1;

FIG. 6 is a view taken along line 6-6 in FIG. 3 and showing a bolus ofbody fluid residing in a capillary test space;

FIG. 7 is a top plan view of a first alternative embodiment of thepresent invention;

FIG. 8 is a view taken along line 8-8 of FIG. 7;

FIG. 9 is a view similar to FIG. 8 showing a second alternativeembodiment of the present invention;

FIG. 10 is a view similar to those of FIGS. 8 and 9 showing a thirdalternative embodiment of the present invention;

FIG. 11 is a top plan view of the embodiment of FIG. 10 with a teststrip removed; and

FIG. 12 is a view similar to FIG. 11 showing a fourth alternativeembodiment of the present invention

DETAILED DESCRIPTION

With reference to the various drawing figures in which identicalelements are numbered identically throughout, a description of apreferred embodiment will now be provided. Throughout this description,the present invention will be described with reference to collecting asample of interstitial fluid for glucose testing using a narrow needlethat penetrates into, but not through, the dermis as more fullydescribed in commonly assigned U.S. Pat. Nos. 5,823,973 and 5,820,570,the disclosures for both of which are hereby incorporated herein byreference. While such a use is a preferred embodiment, the presentinvention is applicable to other fluid collection systems (e.g. bloodcollection) as well as testing for other fluid analytes. Further, thepresent invention is described with reference to using electro-chemicaltesting of a collected sample. The teachings of the present inventionare equally applicable to other testing methods such as colormetrictesting and IR absorption testing.

Referring now to FIGS. 1-6, a collection apparatus 10 includes a mainbody 12 and a test strip 14. The main body has a handle 16 and aneedle-containing ferrule 18. The ferrule 18 holds a hollow needle 20extending from a penetration end 22 to a discharge end 24. Thepenetration end 22 protrudes from a radially spaced ring end 26 of theferrule 18.

In a preferred embodiment, the penetration end 22 is axially spaced fromring end 26 by a distance sufficient for the needle 20 to penetrate intobut not through a patient's dermis to collect a sample of substantiallyblood-free interstitial fluid as taught in U.S. Pat. No. 5,820,570. Insuch an embodiment, the outer diameter of the needle is about 0.013inch.(about 0.33 mm). This sizing of the needle permits substantiallypain-free penetration of the needle to collect a body fluid. Thisdescription illustrates a preferred embodiment. Needle 20 may be sizedto collect any body fluid such as blood or interstitial fluid. Further,the present invention is disclosed where the skin penetration member(i.e., the needle 20) also serves as a conduit for supplying fluid to areservoir 30 as will be described. The present invention is alsoapplicable to any conduit for transporting a body fluid (e.g., acapillary tube as described in International Application PCT/US97/08400published Nov. 20, 1997 as International Publication No. WO 97/42883).

The test strip 14 contains exposed test components on an inner surface14 a. The test components are shown in the form of electrodes 32 fortesting a body fluid for an analyte such as glucose throughelectro-chemical testing. As previously described, the test componentscould be components for alternate testing techniques such as colormetricor IR absorption testing.

Not shown is a housing for holding the apparatus 10 during samplecollection and testing. Housings for holding disposable body fluidsamplers are shown in U.S. Pat. No. 5,823,973. Such housings may containelectrical components for electrical connection to the test stripelectrodes 32 to connect a signal from the electrodes 32 to logiccircuits to compute and report on the analyte in response to signalsfrom the electrodes 32 during testing.

The material of the main body 12 defines a cylindrical reservoir 30having a cylindrical axis between a first end 34 and a second end 36. Inthe embodiment shown, the axis of the reservoir 30 is perpendicular tothe axis of the needle 20. Such a relative alignment is not necessaryfor adequate function and any other alignment is acceptable.

The reservoir 30 has a volume at least as great as a desired test volumeof body fluid to be tested. In a preferred embodiment, reservoir 30 hasa volume of 0.7 microliters. As will become apparent, fluid is collectedin the reservoir 30 and accumulates with a fluid level rising from thefirst end 34 toward the second end 36. Due to such small volumes and thegeometry of reservoir 30, surface tension assures the fluid is retainedin the reservoir 30 with the fluid level rising as described regardlessof the orientation of the apparatus 10 (i.e., the operation of theapparatus 10 is gravity independent).

The discharge end 24 of the needle 20 is disposed within the reservoir30 adjacent the first end 34. Accordingly, body fluid is transportedfrom the penetration end 22, through needle 20 and discharged from thedischarge end 24 into the reservoir 30 at the first end 34.

The material of the body 12 also defines an enlarged empty volume 38positioned between the reservoir 30 and the ferrule 18 and surroundingthe needle 20. The enlarged volume 38 is separated from the reservoir 30by material of the main body pinching against the needle 20 as atlocations 40. The enlarged volume 38 has a volume larger than thereservoir 30 and ensures that fluid within the reservoir 30 is retainedwithin reservoir 30 as it accumulates. For example, in the absence ofenlarged volume 38, manufacturing tolerances may result in a narrowspacing between the material of main body 12 and needle 20. Such anarrow spacing could function as a capillary space communicating withreservoir 30 which would wick fluid out of reservoir 30. The enlargedvolume 38 precludes such capillary wicking. Further, the materialdefining the volume 38 is preferably hydrophobic to minimize wicking. Inthe event precise manufacturing permits complete liquid-tight sealingaround needle 20, the enlarged volume 38 could be eliminated.

The test strip 14 is secured to the main body (e.g., through adhesives)with the inner surface 14 a facing the main body 12 and overlying thesecond end 36 of the reservoir 30. The main body 12 includes a groove 42shaped complementary to the outer periphery of the test strip 14 toensure accurate alignment of the test strip 14 with the main body 12.Adjacent its outer periphery, the inner surface 14 a of the test strip14 includes spacers 44 (shown best in FIG. 6). The spacers 44 insureuniform and close parallel spacing of the inner surface 14 a from a teststrip opposing surface 12 a of the main body 12 for reasons that willbecome apparent. Alternatively, spacers could be formed on the body 12thereby eliminating the need for spacers 44.

The test strip opposing surface 12 a includes a step 46. With referenceto FIG. 6, the construction described above results in formation of acapillary test space 48 defined between opposing surfaces of the teststrip inner surface 14 a and step 46.

As shown in FIG. 6, the spacers 44 are spaced from opposing surfaces ofthe step 46 thereby defining enlarged volumes 50 on opposite sides ofthe step 46. The enlarged volumes 50 perform a function similar to thatof enlarged volume 38. Namely, if the spacers 44 were sized to abut step46, small capillary spaces could form between the spacers 44 and step46. Such capillary spaces could wick fluid from the fluid receivingvolume 48. Again, if manufacturing could ensure a fluid-tight sealbetween spacers 44 and step 46, the volumes 50 could be eliminated.

Shown best in FIGS. 4 and 6, the electrodes 32 are positioned opposingthe step 46. Further, the spacing S (FIG. 4) between the step 46 andinner surface 14 a is uniform and is selected to be sufficiently narrowfor the capillary test space 48 to act as a capillary space to wickfluid from the reservoir 30. An entrance end 52 of the capillary testspace 48 is positioned at the second end 36 of the reservoir 30 (FIG.4). The preferred spacing S is about 0.003-0.005 inch (about 0.075 mm to0.125 mm). The spacing S may be as large as 0.012 inch (about 0.300 mm)or larger depending on the surface tension and volume of the fluid beingcollected and the relative hydrophobic/hydrophilic characteristics ofthe main body 12 and test strip 14.

A hole 54 is formed through the body 12 and into the fluid receivingvolume 48 on a side of the step 46 opposite the reservoir 30. The hole54 permits air in the capillary test space 48 to be vented to atmosphereas fluid flows into the capillary test space 48 from the reservoir 30.Volumes 50 also provide venting.

An additional advantage of this embodiment is its ability to minimizethe effects of sample concentration via evaporation. The total airvolume contained within the enclosed sections substantially defined byvolume 38, reservoir 30, the capillary test space 48, and adjoiningvolumes spaces, is sufficiently small so as to provide a very lowcapacity for evaporation of water from the aqueous sample beingcollected. In addition, the location of the vent and the overallgeometry discourage convective passage of air through the aforementionedspaces, minimizing any convective acceleration of evaporation. Whendealing with small volumes (e.g. less than 1 microliter), minimizingevaporative losses can be important to maintaining the integrity of thesample for quantitative analysis.

With the construction thus described, the apparatus 10 is used by urgingthe ring end 26 against a patient's skin. The penetration tip 22penetrates the skin. The ring end 26 (being radially spaced from tip 22)acts to urge fluid into the needle 20. The fluid flows along the needle20 and discharges into the first end 34 of the reservoir 30 throughdischarge end 24. In one possible embodiment, suction could be appliedto advance the rate of flow of fluid through needle 20. Suction is notused in other embodiments.

Fluid accumulates in the reservoir 30 with a level of accumulated fluidgrowing from the first end 34 to the second end 36. When the fluid levelreaches the second end 36, a desired volume of fluid to be tested hasaccumulated in the reservoir 30. At this time, the fluid level contactsthe entrance end 52 of the capillary test space 48. Since the capillarytest space 48 is a narrow capillary space, the fluid is rapidly wickedout of the reservoir 30 and into the capillary test space 48 as a bolusdelivery of fluid indicated by the bolus of fluid 56 in FIG. 6. Sopositioned, the fluid is in contact with the electrodes 32 and testingof the fluid may commence.

The present invention permits fluid contact with the electrodes 32 onlyafter an adequate volume of fluid has been collected. By way ofnon-limiting representative example, it may take thirty seconds forfluid to fill the reservoir 30 and only one second for the accumulatedfluid to be wicked into the capillary test space 48 from the reservoir30. As a result, the present invention avoids a long period of timeduring which fluid is contacting the electrodes 32 and before testingmay commence. Further, without the need for specialized electronics asused in the prior art, testing cannot commence until after an adequatevolume of fluid has been accumulated. Therefore, when a signal isreceived from electrodes 32, it is known that an adequate volume offluid is opposing the electrodes 32.

The retention of fluid in the reservoir 30 and wicking of fluid into thecapillary test space 48 can be controlled and modified by varying thedimensions of the components as will be apparent to one of ordinaryskill in the art having the benefit of the teachings of the presentinvention. Further, as will be apparent to such artisan, such retentionand wicking may also be controlled and modified through materialselection. For example, it is desirable that the main body 12 be formedof hydrophobic material and that the capillary test space 48 be morehydrophilic. For example, a hydrophilic surfactant may be applied tostep 46 or test strip inner surface 14 a (or both) to make the capillarytest space 48 more hydrophilic than the reservoir 30.

It may be desirable to have one of electrodes 32 completely wetted withfluid from reservoir 30 before the other of the electrodes 30 is wetted.FIGS. 7-12 illustrate several alternative embodiments for achieving suchsequential wetting. In the embodiments, elements in common with thosealready described are numbered identically with the addition of lettersuffices (i.e., “a”, “b”, “c” and “d”). Such elements are not separatelydescribed unless modified by the alternative embodiment.

In Fills. 7 and 8, it is desirable to completely wet electrode 32 abetore wetting electrode 32 a′. The electrodes 32 a, 32 a′ arepositioned side-by-side on test strip 14 a and equidistant fromreservoir 30 a. As shown in FIG. 8, the step 46 of the previouslydescribed embodiment is divided into two steps 46 a, 46 a′ opposingrespective ones of electrodes 32 a, 32 a′. A hydrophobic volume 50 a′ ispositioned between the steps 46 a, 46 a′. The volume 50 a′ functionssimilarly to side volumes 50 a (and 50 in the embodiment of FIG. 6) toact as a hydrophobic barrier to prevent fluid from flowing between thesteps 46 a, 46 a′. The steps 46 a, 46 a′ are spaced from test strip 14by spaces Sa and Sa′. Since space Sa is smaller than space Sa′, fluidfirst flows from reservoir 30 a into space Sa before flowing fromreservoir 30a into space Sa′.

In the embodiment of FIG. 9, fluid is inclined to first flow onto step46 b before onto step 46 b′. However, in FIG. 9, the volume barrier 50a′ of FIG. 8 has been replaced with a ramp surface 47 b connecting steps46 b and 46 b′. Therefore, fluid can flow from space Sb to space Sb′after space Sb has first filled with fluid.

In the embodiment of FIGS. 10 and 11, the steps 46 c, 46 c′ arepositioned on opposite sides of the reservoir 30 c. If spaces Sc and Sc′are equal, fluid flows simultaneously into the spaces Sc and Sc′ butdoes not flow between the spaces Sc and Sc′. The spaces Sc and Sc′ maybe varied to change the rate of flow into the spaces Sc and Sc′.

The embodiment of FIG. 12 is similar to that of FIG. 9. Instead of theramp 47 b of FIG. 9 (which connects steps 46 b and 46 b′ directly acrossa side-to-side path), the ramp 47 d is U-shaped for fluid to flow fromstep 46 d to step 46 d′ in a U-shaped path A on a side of the steps 46d, 46 d′ opposite the reservoir 30 d.

From the foregoing detailed description, the present invention has beendescribed in a preferred embodiment. Modifications and equivalents ofsuch disclosure are intended to be included in the appended claims. Forexample, either or both of the reservoir 30 and capillary test space 48need not be an empty volume but could be filled with an absorbentmaterial.

1-8. (canceled)
 9. An apparatus for use with a test strip and for collecting a body fluid for testing for an analyte contained within said body fluid, said apparatus comprising: a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit; and a test strip opposing surface for contacting a surface of said test strip wherein, when said test strip is in contact with said test strip opposing surface, a capillary test space is formed there between wherein said capillary test space is positioned to be in fluid communication with said reservoir and sized to wick a transfer volume of said body fluid from said reservoir when said fluid in said reservoir attains said transfer volume.
 10. The apparatus of claim 9, wherein said test strip opposing surface defines at least one step wherein said capillary test space is defined between said surface of said test strip and said at least one step.
 11. The apparatus of claim 10, wherein a space having an enlarged volume is provided on each side of said at least one step.
 12. The apparatus of claim 9, wherein said test strip comprises at least one electrode positioned opposing said at least one step.
 13. The apparatus of claim 10, wherein said test strip opposing surface defines two steps separated by a hydrophobic volume wherein a first capillary test space is defined between said test strip surface and a first step and a second capillary test space is defined between said test strip surface and a second step.
 14. The apparatus of claim 13 wherein said test strip comprises a first electrode positioned opposing said first step and a second electrode positioned opposing said second step, wherein the configuration of said test strip opposing surface provides for the wetting of said first electrode by said transfer volume of body fluid prior to the wetting of said second electrode by said transfer volume.
 15. The apparatus of claim 13 wherein said hydrophobic volume comprises a ramped surface.
 16. The apparatus of claim 15 wherein said ramped surface is U-shaped.
 17. The apparatus of claim 9 wherein one or both of the reservoir and capillary test space are filled with an absorbent material.
 18. The apparatus of claim 9 wherein: said reservoir includes first and second spaced-apart ends; said discharge end of said conduit is disposed adjacent said first end; and said capillary test space is disposed adjacent said second end.
 19. The apparatus of claim 18 wherein a volume of said reservoir between said first and second ends of said reservoir is sized to be at least as great as said transfer volume.
 20. The apparatus of claim 9 wherein said reservoir has a size and geometry providing a surface tension which assures said fluid is retained within said reservoir.
 21. The apparatus of claim 9 further comprising an enlarged volume adjacent said reservoir wherein said enlarged volume is greater than the volume of said reservoir.
 22. The apparatus of claim 21 wherein said enlarged volume is defined by a hydrophobic material.
 23. The apparatus of claim 9 further comprising a groove comprising a shape corresponding to the outer periphery of the test strip.
 24. An apparatus for use with a test strip and for collecting a body fluid for testing for an analyte contained within said body fluid, said apparatus comprising: a conduit comprising a fluid access end and a fluid discharge end, said conduit configured for wicking said body fluid from said access end to said discharge end; and a test strip opposing surface for contacting a surface of said test strip wherein, when said test strip is in contact with said test strip opposing surface, a capillary test space is formed there between wherein said capillary test space is proximal to said conduit discharge end and sized to wick a transfer volume of said body fluid from said conduit when said fluid in said conduit attains said transfer volume. 